510(k) · Cleared
ClearedWallflex Enteral Colonic Stent with Anchor Lock Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MQR Stent, Colonic, Metallic, Expandable
Cleared on Sep 15, 2006 as substantially equivalent to K042065 (Boston Scientific Corp, 2004) and 2 other predicates after a 74-day review. Its family tree reaches back 2 generations to 2000. 10 later devices descend from it.
- Decided
- Sep 15, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- MQR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000281 (2000). 4 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 1 generation backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- This deviceK061877 Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp · 2006
- Descendant · cites it directly · 4 of its ownK180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM…M.I.Tech Co., Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx…M.I.Tech Co., Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK113510 Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012
- Descendant · 3 generations on · 2 of its ownK190141 HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent…Cook Ireland, Ltd. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd. · 2018 · cites it directly4descendants
- K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd. · 2019 · 2 generations on3descendants
- K113510Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012 · cites it directly3descendants
- K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019 · 3 generations on2descendants
- K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −1 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| 0 (this device) | K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery System | Boston Scientific Corp | 2006 | — |
| +1 | K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus… | M.I.Tech Co., Ltd. | 2018 | — |
| +2 | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| +1 | K113510 | Evolution Colonic Stent System | Cook Ireland, Ltd. | 2012 | — |
| +3 | K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| +2 | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -… | Cook Ireland, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQR device
- #1 K234046 WallFlex Colonic Stent System with Anchor Lock…score 8.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemSummary page 1…ification: Class II 3. Predicate Device(s): > Boston Scientific Corporation's WallflexTM Enteral Colonic Stent with Anchor Lock Delivery System, K042065 Boston Scientific Corporation's UltraflexTM PrecisionTM Colonic Stent System, K060323 Boston… | 2004 |
| * | K060323 | Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380Summary page 1…Colonic Stent with Anchor Lock Delivery System, K042065 Boston Scientific Corporation's UltraflexTM PrecisionTM Colonic Stent System, K060323 Boston Scientific Corporation's Wallstent® Enteral Prosthesis, K000281 All above predicates are class II d… | 2006 |
| * | K000281 | Wallstent Enternal ProsthesisSummary page 1…ton Scientific Corporation's UltraflexTM PrecisionTM Colonic Stent System, K060323 Boston Scientific Corporation's Wallstent® Enteral Prosthesis, K000281 All above predicates are class II devices per 21 CFR 878.3610 4. Device Description: The proposed Wallfl… | 2000 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | 2018 | 4 |
| K113510 | Evolution Colonic Stent System | 2012 | 3 |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery System | 2020 | 1 |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal… | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K180180 (M.I.Tech Co., Ltd., 2018) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K042065.
How does its category compare?
All MQR devicesMQR Stent, Colonic, Metallic, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQR
Too few MQR 510(k)s in any year since 2007 to give a median.
Recalls per year · MQR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQR
29in 2025
MAUDE reports naming product code MQR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 30 |
| 2008 | 0 | — | 0 | 144 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 0 | — | 1 | 71 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 1 | — | 0 | 104 |
| 2013 | 0 | — | 0 | 100 |
| 2014 | 0 | — | 0 | 70 |
| 2015 | 0 | — | 0 | 72 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 1 | — | 0 | 44 |
| 2019 | 2 | — | 0 | 42 |
| 2020 | 2 | — | 0 | 46 |
| 2021 | 0 | — | 0 | 56 |
| 2022 | 0 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 38 |
| 2024 | 1 | — | 0 | 70 |
| 2025 | 0 | — | 0 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The WallfleXTm Enteral Colonic Stent with Anchor Lock Delivery System is indicated for
palliative treatment of colonic strictures caused by malignant neoplasms and to relieve
large bowel obstruction prior to colectomny in patients with malignant strictures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061877: Wallflex Enteral Colonic Stent with Anchor Lock Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061877
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026